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A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Trial Information

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Bone is the third most common organ involved by metastatic disease behind lung and liver
[6]. In breast cancer, bone is the second most common site of metastatic spread, and 90% of
patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize
to bone most frequently, which reflects the high incidence of both these tumors, as well as
their prolonged clinical courses. Post-cancer survival has increased with improvement in
early detection and treatments. As a consequence, the number of patients developing
metastatic bone disease during their lifetime has also increased.

Current treatments for patients with bone metastases are primarily palliative and include
localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal
therapy, radiopharmaceutical, and bisphosphonates although the primary goal of the use of
these therapies are often to address the disease itself), and analgesics (opioids and
non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested
as a treatment option for bone metastases [8]. Currently, an off label use of Cryoablation
techniques are being tested as another alternative for bone Mets palliation. The main
goals of these treatments are improvement of quality of life and functional level. These
goals can be further described:

1. Pain relief

2. Preservation and restoration of function

3. Local tumor control

4. Skeletal stabilization

Treatment with external beam radiation therapy (EBRT) is the standard of care for patients
with localized bone pain, and results in the palliation of pain for many of these patients.
Twenty to 30% of patients treated with radiation therapy do not experience pain relief
[9-13]. Re-treatment rates are generally reported in the range of 10-25%. Many patients
with relapsed pain or poor response to initial radiation may be lost to follow up or may not
be referred back to oncologists for consideration of re-radiation. In addition to relapse
and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation
period. The fracture rate reported in radiation studies is generally in the range of 1% to
8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous
fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may
not be eligible for further radiation therapy secondary to limitations in normal tissue
tolerance. Hesitation on the part of physicians to use a larger dose may be related to
increased long-term toxicity. Larger radiation dose produces a greater risk of
complications such as fibrosis of normal soft tissue, which can cause a decrement in the
quality of life in cases of life expectancy longer than 6 months. There may also be a
greater incidence of acute side effects of nausea and vomiting if the treatment field
includes the stomach. The percent of patients experiencing vomiting following EBRT ranges
from about 5% to 30%.

A palliative treatment for painful bone metastases that is non-invasive, without long-term
toxicity and having minimal complications would be a useful tool for treating physicians and
also a beneficial option for patients suffering from painful bone metastases. Results of
preliminary studies indicate that ExAblate treatment of painful bone metastases may be a
beneficial treatment option [14, 15]. The ExAblate system is a non-invasive thermal
ablation device used in the coagulation of various types of soft tissue. The ExAblate
system has the potential to achieve the first three of the four previously mentioned goals
in the treatment of bone tumors; namely pain relief, preservation and restoration of
functional levels and local tumor control [11]. The ExAblate system used in the present
study is a technological advance over the ExAblate 2000 fixed transducer system in terms of
flexibility of use and reduction of positioning related pain to the patients. The ExAblate
system used in this study conforms to the patient's body shape at the location of the bone
mets location.

Inclusion Criteria:

1. Men and women age 18 and older

2. Patients who are able and willing to give consent and able to attend all study visits

6. Patients with persistent distinguishable pain associated with up to 3 tumors of which
a maximum of 2 tumors will be treated:

o If patient has pain from additional sites that are not planned for treatment, the
pain from the additional sites must be evaluated as being less intense by at least 2
points on the NRS compared to the site(s) to be treated.

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